According to the long-awaited Final Rule of the Physician Payment Sunshine Act (Sunshine Act), companies will have to start collecting data on their “payments or transfers of value” to physicians starting on August 1, 2013. Other provisions within the Final Rule differ significantly from the Proposed rule released in January 2012: the Final Rule adds new terms, re-defines other key terms, provides exemptions for certain Continuing Medical Education speaking payments and clarifies reporting protocols.
The Coalition for Imaging and Bioengineering Research (CIBR) offered comments from the imaging research community on the Proposed Rule in February 2012, particularly as the Rule related to academic-industrial research partnerships. A number of CIBR’s recommendations were included in the Final Rule.
- Manufacturers are no longer required to report “direct” and “indirect” research support. For example, if an investigator at an academic medical college received a research grant from a manufacturer, the Proposed Rule would have required the manufacturer to report both the “direct” support to the investigator, and file a separate report listing the same amount of funding as “indirect” funding to the institution. CIBR opposed this proposal on the grounds that it would double-count research funding in the system, leading to misconceptions from the public. Per CIBR’s suggestion, the Final Rule only requires the research funding to list the institution and the amount, with a Principal Investigator (PI) identified. (Section 403.904(f) Final Rule)
- In addition to eliminate the potential for “double-counting” of research dollars, CMS also took CIBR’s suggestion to include a reporting field for “Research Description.” This would give the manufacturer and the PI the option of providing some context on their research for the public, similar to the Public Health Relevance Statements required by the National Institutes of Health (NIH). This would be an optional field as to protect sensitive research protocols, but would provide many researchers the opportunity to better explain to the public the scientific goals of the research partnership. It also gives PIs and the manufacturer the ability to provide a link to the clinicaltrials.gov website so interested members of the public can find information on enrolling in listed trials. (Section 403.904(f) Final Rule)
- The Final Rule does not require manufacturers to calculate the estimated cost of food and beverage per attendee at large scale conferences and meetings. (403.904(h) Final Rule)
- The Final Rule clarifies that manufacturers and researchers do not need to provide research protocols and written agreements to CMS to verify bona fide research activity subject to a four-year embargo. This will ensure that proprietary and potentially sensitive research documents are not being transmitted and stored on CMS servers.
CIBR is continuing to analyze the Final Rule and will publish additional educational material in the coming weeks.